BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSIA BREEZE2

    MDR report key: 1111003 · Received August 8, 2008

    Report

    Report Number
    1826988-2008-00846
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 11, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED SHE CALLED PARAMEDICS BECAUSE THE CUSTOMER WAS PALE AND VOMITING. THE PARAMEDICS TESTED THE CUSTOMER'S BLOOD GLUCOSE USING THEIR METER AND RECEIVED A READING OF 40 MG/DL. THE CUSTOMER'S GLUCOSE WAS ALSO TESTED USING HIS BREEZE2 METER AND THE READING WAS 80 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALL IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. THE CUSTOMER DISPOSED OF HIS TEST STRIPS, BUT HIS METER IS TO BE RETURNED FOR EVALUATION. A NEW METER KIT WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA BREEZE2 BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 1440 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention